Systematic Literature Review of AbobotulinumtoxinA in Clinical Trials for Adult Upper Limb Spasticity

Abstract

ObjectiveThe aim of this study was to elucidate clinical trial efficacy, safety, and dosing practices of abobotulinumtoxinA (ABO) treatment in adult patients with upper limb spasticity (ULS).MethodsA systematic literature review was performed to identify randomized controlled trials and other comparative clinical studies of ABO in the treatment of adult ULS published in English between January 1991 and January 2013. Medical literature databases (PubMed, Cochrane Library, and EMBASE) were searched, and a total of 295 records were identified. Of these, 12 primary publications that evaluated ABO for the management of ULS were included in the final data report.SynthesisTotal ABO doses ranged between 500 and 1500 U for ULS. Most of the studies in ULS showed statistically significant benefits (reduction in muscle tone based on Ashworth score) of ABO vs. placebo. Statistical significance was reached for most evaluations of spasticity using the Modified Ashworth Scale. Statistically significant effects on active movement and pain were demonstrated, albeit less consistently. ABO was generally well tolerated across the individual studies; most adverse events reported were considered unrelated to treatment. Adverse events considered associated with ABO treatment included fatigue, tiredness, arm pain, skin rashes, flu-like symptoms, worsening of spasm, and weakness.ConclusionsOn the basis of data extracted from 12 randomized clinical studies, a strong evidence base (9/12 studies) exists for the use of ABO to reduce ULS caused by stroke.

Effects of repeated abobotulinumtoxinA injections in upper limb spasticity

“…1,2 Botulinum toxin A (BoNT-A) is a first-line treatment for muscle overactivity in spastic paresis, [3][4][5] and coupling injections with neurorehabilitation may improve outcomes. [6][7][8] Although numerous studies have reported post-stroke or -TBI benefits of abobotulinumtoxinA (Dysport; Ipsen) on muscle tone 4,[9][10][11][12][13][14][15][16][17][18][19][20][21] and passive function 4,9,14,17 for up to 24 weeks after a single injection, its effects on active function remained uncertain. 3,4,19,21,22 Few studies have addressed the safety and efficacy of repeated BoNT-A injections and none have shown effects on active movement.…”

Dose‐Dependent Effects of AbobotulinumtoxinA (Dysport) on Spasticity and Active Movements in Adults With Upper Limb Spasticity: Secondary Analysis of a Phase 3 Study

“…None of these studies provided joint‐specific outcomes associated with abobotulinumtoxinA dose. Despite our standardized protocol [20], our data likely reflect real‐world injections in that numerous different muscle and dose injection combinations were used, as in past studies [8,13,14,17,19].…”

“…Evidence‐based information on optimal dosing for clinical use is relatively sparse. Dosing is not interchangeable between different BoNT‐A products; therefore, improving our understanding of product‐specific dosing will minimize confusion among injectors and improve the quality of patient care [13].…”

“…Among BoNT‐A formulations, abobotulinumtoxinA (Dysport; Ipsen Biopharm, Wrexham, United Kingdom) has been shown to decrease muscle tone (as measured by the Modified Ashworth Scale [MAS]) [13‐17] and pain [18] and to facilitate goal attainment [19] in adults with ULS. A recent systematic review [13] of 12 randomized controlled trials (RCTs) in ULS concluded that abobotulinumtoxinA (total dose range, 500‐1500 U) was generally well‐tolerated, with “strong evidence” to support reduced muscle tone.…”

Spastic Paresis and Rehabilitation – The Patient Journey

“…These different treatment options are discussed in more detail in the guidelines in Table 2 and in other review papers. 32,[43][44][45] Financial and administrative barriers …”